Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Randomized Phase I/II Study of ABT-888 in Combination With Temozolomide in Recurrent (Temozolomide Resistant) Glioblastoma
RATIONALE: Veliparib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as temozolomide. work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving veliparib together with temozolomide may kill more tumor cells.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of
giving veliparib together with temozolomide and to see how well it works in treating
patients with recurrent glioblastoma.
OBJECTIVES:
Primary
- To define the maximum-tolerated dose of the combination of temozolomide and veliparib
in patients with recurrent glioblastoma previously or not treated with temozolomide.
(Phase I*)
- To determine the efficacy of the combination of temozolomide and veliparib (using a
5-day vs 21-day schedule) as measured by the 6-month progression-free survival rate in
patients with recurrent glioblastoma previously treated with temozolomide. (Phase II*)
Secondary
- To characterize the safety profile of the combination of temozolomide and veliparib.
(Phase I*)
- To determine the adverse event profile and tolerability of the combination of
temozolomide and veliparib (using a 5-day vs 21-day schedule) in patients with
recurrent glioblastoma. (Phase II*)
- To determine the efficacy of the combination of temozolomide and veliparib (using a
5-day vs 21-day schedule) as measured by objective response in patients with measurable
disease. (Phase II*)
- To determine the overall survival of patients with measurable disease treated with the
combination of temozolomide and veliparib (using a 5-day vs 21-day schedule). (Phase
II*) NOTE: *Phase I was closed and phase II was opened on 3/6/12.
OUTLINE: This is a multicenter, phase I* dose-escalation study followed by a phase II*
randomized study. Patients enrolled in the phase II portion are stratified according to
bevacizumab status (bevacizumab-naive vs bevacizumab-failure), age (< 50 years vs ≥ 50
years), Karnofsky performance status (70-80% vs 90-100%), and recent resection (yes vs
no/biopsy only).
- Phase I:* Patients receive oral temozolomide once daily and oral veliparib twice daily
on days 1-21. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
- Phase II:* Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive temozolomide and veliparib as in phase I.
- Arm II: Patients receive oral temozolomide once daily and oral veliparib twice
daily on days 1-5. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 1 year,
every 26 weeks for 2 years, and then annually thereafter.
NOTE: *Phase I was closed and phase II was opened on 3/6/12.
PROJECTED ACCRUAL: A total of 240 patients (28 for phase I* and 212 for phase II*) will be
accrued for this study.
NOTE: *Phase I was closed and phase II was opened on 3/6/12.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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